The role holder provides leadership and direction in area of expertise on Pharmacovigilance (PV) including but not limited to be responsible for PV coordination and management to ensure PV inspection readiness at all times.
1.To set up PV work process and lead PV functional team.
2.To manage PV system and reporting for clinical trials.
3.To be responsible for Risk Mitigation Plan.
4.To coordinate PV related work globally.
5.To oversight CRO in PV area.
6.To review PV data during clinical trials and CSR.
7.To support investigators in PV area.
8.To support clinical team in PV area.
9.To complete other assigned work as one of clinical team.
1.Master degree or above in medicine.
2.At least 5 years PV experience, oncology/immunology area is preferred.
3.With ICH-GCP/GCP training.
4.Familiar with regulatory requirements on PV.
5.With good English skills (oral and writing).
6.With good teamwork abilities.
With good computer skills.